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Tag: FDA

September 16, 2022December 22, 2022 stevensevert2

FDA Issues New Draft Guidance on Medical Device Quality System Software Assurance

September 2, 2022December 22, 2022 stevensevert2

The State of Pharmaceutical Quality FY21

July 27, 2022December 22, 2022 stevensevert2

FDA Releases New Draft Guidance for Remote Regulatory Assessments

July 1, 2022July 27, 2022 stevensevert2

FDA Virtual Inspections Are Here to Stay – And That’s a Good Thing

February 23, 2022December 22, 2022 stevensevert2

After Years of Delays, FDA Finally Issues Proposed Rule to Harmonize QSR to ISO 13485

February 4, 2022December 22, 2022 stevensevert2

Is My Product a Medical Device?

November 28, 2021December 22, 2022 stevensevert2

Free Whitepaper: Clause-by-Clause Explanation of ISO 13485:2016

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